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Breakthrough on Antipsychotic Maintenance Medication: An Individual Participant Data Meta-Analysis.
Proposal
2056
Title of Proposed Research
Breakthrough on Antipsychotic Maintenance Medication: An Individual Participant Data Meta-Analysis.
Lead Researcher
Jose M Rubio M.D.
Affiliation
The Zucker Hillside Hospital,
The Feinstein Institute of Biomedical Research
Northwell Health
Funding Source
None
Potential Conflicts of Interest
Dr. Kane receives honoraria from Alkermes, Eli Lilly, EnVivo Pharmaceuticals (Forum), Forest (Allergan), Genentech, H. Lundbeck, Intracellular Therapeutics, Janssen Pharmaceutica, Johnson and Johnson, Neurocrine, Otsuka, Pierre Fabre, Reviva, Roche, Sunovion, Takeda, and Teva as a consultant for expert testimony; receives honoraria from Alkermes, Intracellular Therapies, Lundbeck, Neurocrine, Otsuka, Pierre Fabre, Takeda and Teva as an advisory board member; receives stock from Medavante Inc., Vanguard Research Group, LB Pharmaceuticals, Inc., as a shareholder, receives grant support form Otsuka and Janssen as an investigator
Data Sharing Agreement Date
01 February 2018
Lay Summary
Antipsychotic drugs are effective in reducing the risk of relapse in schizophrenia. However, about 15% of patients relapse despite optimal adherence with maintenance antipsychotic treatment. This phenomenon is known as breakthrough on antipsychotic maintenance medication (BAMM), and represents an important challenge in the long-term treatment of schizophrenia. Understanding the factors involved in relapse despite adherence with antipsychotic maintenance treatment is important to develop early interventions for these individuals, as well as to understand the mechanisms underlying this phenomenon. We aim to capitalize on existing data from randomized controlled trials of maintenance treatment clinical trials of long acting injectable antipsychotics in schizophrenia to study the factors involved in BAMM. We will do so by pooling data from various of these studies in what is known as an individual participant data meta-analysis. This is a powerful statistical technique to study risk factors as they occur across various comparable clinical samples. We believe that this work will be very useful in understanding what are the risk factors of BAMM, and therefore who are the individuals that should receive early intervention, as well as what are the potential mechanisms involved in the failure to respond to maintenance antipsychotic treatment in schizophrenia.
Study Data Provided
[{ "PostingID": 1654, "Title": "LILLY-F1D-MC-HGJZ", "Description": "A Double-Blind Randomized Study Comparing Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
Medicine: Olanzapine pamoate, Condition: Schizophrenia, Phase: 3, Clinical Study ID: F1D-MC-HGJZ, Sponsor: Lilly" },{ "PostingID": 2101, "Title": "LILLY-F1D-MC-HGKA", "Description": "A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia
Medicine: Olanzapine pamoate, Condition: Schizophrenia, Phase: 3, Clinical Study ID: F1D-MC-HGKA, Sponsor: Lilly" },{ "PostingID": 2102, "Title": "LILLY-F1D-MC-HGKB", "Description": "An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Medicine: Olanzapine pamoate, Condition: Schizophrenia, Phase: 3, Clinical Study ID: F1D-MC-HGKB, Sponsor: Lilly" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
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